Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial

Yuan Zhang; Lei Chen; Guo Qing Hu; Ning Zhang; Xiao Dong Zhu; Kun Yu Yang; Feng Jin; Mei Shi; Yu Pei Chen; Wei Han Hu; Zhi Bin Cheng; Si Yang Wang; Ye Tian; Xi Cheng Wang; Yan Sun; Jin Gao Li; Wen Fei Li; Yu Hong Li; Yan Ping Mao; Guan Qun Zhou; Rui Sun; Xu Liu; Rui Guo; Guo Xian Long; Shao Qiang Liang; Ling Li; Jing Huang; Jin Hua Long; Jian Zang; Qiao Dan Liu; Li Zou; Qiong Fei Su; Bao Min Zheng; Yun Xiao; Ying Guo; Fei Han; Hao Yuan Mo; Jia Wei Lv; Xiao Jing Du; Cheng Xu; Na Liu; Ying Qin Li; Fang Yun Xie; Ying Sun; Jun Ma; Ling Long Tang

doi:10.1200/JCO.22.00327

Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial

Yuan Zhang, Lei Chen, Guo Qing Hu, Ning Zhang, Xiao Dong Zhu, Kun Yu Yang, Feng Jin, Mei Shi, Yu Pei Chen, Wei Han Hu, Zhi Bin Cheng, Si Yang Wang, Ye Tian, Xi Cheng Wang, Yan Sun, Jin Gao Li, Wen Fei Li, Yu Hong Li, Yan Ping Mao, Guan Qun ZhouRui Sun, Xu Liu, Rui Guo, Guo Xian Long, Shao Qiang Liang, Ling Li, Jing Huang, Jin Hua Long, Jian Zang, Qiao Dan Liu, Li Zou, Qiong Fei Su, Bao Min Zheng, Yun Xiao, Ying Guo, Fei Han, Hao Yuan Mo, Jia Wei Lv, Xiao Jing Du, Cheng Xu, Na Liu, Ying Qin Li, Fang Yun Xie, Ying Sun, Jun Ma, Ling Long Tang

Research output: Contribution to journal › Article › peer-review

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Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically on the based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported significantly improved failure-free survival using gemcitabine plus cisplatin induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma. Here, we present the final overall survival (OS) analysis. In this multicenter, randomized trial, patients were assigned to be treated with concurrent chemoradiotherapy alone (standard therapy, n = 238) or gemcitabine and cisplatin induction chemotherapy before concurrent chemoradiotherapy (n = 242). With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9% v 78.8%, hazard ratio, 0.51 [95% CI 0.34 to 0.78]; P =.001) and a comparable risk of late toxicities (≥ grade 3, 11.3% v 11.4%). Notably, the depth of the tumor response to induction chemotherapy correlated significantly and positively with survival (complete response v partial response v stable/progressive disease, 5-year OS, 100% v 88.4% v 61.5%, P =.005). Besides, patients with a low pretreatment cell-free Epstein-Barr virus DNA load (< 4,000 copies/mL) might not benefit from induction chemotherapy (5-year OS, 90.6% v 91.4%, P =.77). In conclusion, induction chemotherapy before concurrent chemoradiotherapy improved OS significantly in patients with locally advanced nasopharyngeal carcinoma, without increasing the risk of late toxicities. Tumor response to induction chemotherapy and pretreatment cell-free Epstein-Barr virus DNA might be useful to guide individualized treatment.

Original language	English
Article number	JCO.22.00327
Journal	Journal of Clinical Oncology
Volume	333
DOIs	https://doi.org/10.1200/JCO.22.00327
State	Published - Feb 1 2022
Externally published	Yes

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10.1200/JCO.22.00327

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Zhang, Y., Chen, L., Hu, G. Q., Zhang, N., Zhu, X. D., Yang, K. Y., Jin, F., Shi, M., Chen, Y. P., Hu, W. H., Cheng, Z. B., Wang, S. Y., Tian, Y., Wang, X. C., Sun, Y., Li, J. G., Li, W. F., Li, Y. H., Mao, Y. P., ... Tang, L. L. (2022). Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial. Journal of Clinical Oncology, 333, Article JCO.22.00327. https://doi.org/10.1200/JCO.22.00327

@article{a5942be638934273926f0ecf3c1fffc6,

title = "Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial",

abstract = "Clinical trials frequently include multiple end points that mature at different times. The initial report, typically on the based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported significantly improved failure-free survival using gemcitabine plus cisplatin induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma. Here, we present the final overall survival (OS) analysis. In this multicenter, randomized trial, patients were assigned to be treated with concurrent chemoradiotherapy alone (standard therapy, n = 238) or gemcitabine and cisplatin induction chemotherapy before concurrent chemoradiotherapy (n = 242). With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9% v 78.8%, hazard ratio, 0.51 [95% CI 0.34 to 0.78]; P =.001) and a comparable risk of late toxicities (≥ grade 3, 11.3% v 11.4%). Notably, the depth of the tumor response to induction chemotherapy correlated significantly and positively with survival (complete response v partial response v stable/progressive disease, 5-year OS, 100% v 88.4% v 61.5%, P =.005). Besides, patients with a low pretreatment cell-free Epstein-Barr virus DNA load (< 4,000 copies/mL) might not benefit from induction chemotherapy (5-year OS, 90.6% v 91.4%, P =.77). In conclusion, induction chemotherapy before concurrent chemoradiotherapy improved OS significantly in patients with locally advanced nasopharyngeal carcinoma, without increasing the risk of late toxicities. Tumor response to induction chemotherapy and pretreatment cell-free Epstein-Barr virus DNA might be useful to guide individualized treatment.",

author = "Yuan Zhang and Lei Chen and Hu, {Guo Qing} and Ning Zhang and Zhu, {Xiao Dong} and Yang, {Kun Yu} and Feng Jin and Mei Shi and Chen, {Yu Pei} and Hu, {Wei Han} and Cheng, {Zhi Bin} and Wang, {Si Yang} and Ye Tian and Wang, {Xi Cheng} and Yan Sun and Li, {Jin Gao} and Li, {Wen Fei} and Li, {Yu Hong} and Mao, {Yan Ping} and Zhou, {Guan Qun} and Rui Sun and Xu Liu and Rui Guo and Long, {Guo Xian} and Liang, {Shao Qiang} and Ling Li and Jing Huang and Long, {Jin Hua} and Jian Zang and Liu, {Qiao Dan} and Li Zou and Su, {Qiong Fei} and Zheng, {Bao Min} and Yun Xiao and Ying Guo and Fei Han and Mo, {Hao Yuan} and Lv, {Jia Wei} and Du, {Xiao Jing} and Cheng Xu and Na Liu and Li, {Ying Qin} and Xie, {Fang Yun} and Ying Sun and Jun Ma and Tang, {Ling Long}",

note = "Publisher Copyright: {\textcopyright} American Society of Clinical Oncology.",

year = "2022",

month = feb,

day = "1",

doi = "10.1200/JCO.22.00327",

language = "English",

volume = "333",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

}

Zhang, Y, Chen, L, Hu, GQ, Zhang, N, Zhu, XD, Yang, KY, Jin, F, Shi, M, Chen, YP, Hu, WH, Cheng, ZB, Wang, SY, Tian, Y, Wang, XC, Sun, Y, Li, JG, Li, WF, Li, YH, Mao, YP, Zhou, GQ, Sun, R, Liu, X, Guo, R, Long, GX, Liang, SQ, Li, L, Huang, J, Long, JH, Zang, J, Liu, QD, Zou, L, Su, QF, Zheng, BM, Xiao, Y, Guo, Y, Han, F, Mo, HY, Lv, JW, Du, XJ, Xu, C, Liu, N, Li, YQ, Xie, FY, Sun, Y, Ma, J & Tang, LL 2022, 'Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial', Journal of Clinical Oncology, vol. 333, JCO.22.00327. https://doi.org/10.1200/JCO.22.00327

TY - JOUR

T1 - Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma

T2 - A Multicenter, Randomized Phase III Trial

AU - Zhang, Yuan

AU - Chen, Lei

AU - Hu, Guo Qing

AU - Zhang, Ning

AU - Zhu, Xiao Dong

AU - Yang, Kun Yu

AU - Jin, Feng

AU - Shi, Mei

AU - Chen, Yu Pei

AU - Hu, Wei Han

AU - Cheng, Zhi Bin

AU - Wang, Si Yang

AU - Tian, Ye

AU - Wang, Xi Cheng

AU - Sun, Yan

AU - Li, Jin Gao

AU - Li, Wen Fei

AU - Li, Yu Hong

AU - Mao, Yan Ping

AU - Zhou, Guan Qun

AU - Sun, Rui

AU - Liu, Xu

AU - Guo, Rui

AU - Long, Guo Xian

AU - Liang, Shao Qiang

AU - Li, Ling

AU - Huang, Jing

AU - Long, Jin Hua

AU - Zang, Jian

AU - Liu, Qiao Dan

AU - Zou, Li

AU - Su, Qiong Fei

AU - Zheng, Bao Min

AU - Xiao, Yun

AU - Guo, Ying

AU - Han, Fei

AU - Mo, Hao Yuan

AU - Lv, Jia Wei

AU - Du, Xiao Jing

AU - Xu, Cheng

AU - Liu, Na

AU - Li, Ying Qin

AU - Xie, Fang Yun

AU - Sun, Ying

AU - Ma, Jun

AU - Tang, Ling Long

PY - 2022/2/1

Y1 - 2022/2/1

N2 - Clinical trials frequently include multiple end points that mature at different times. The initial report, typically on the based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported significantly improved failure-free survival using gemcitabine plus cisplatin induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma. Here, we present the final overall survival (OS) analysis. In this multicenter, randomized trial, patients were assigned to be treated with concurrent chemoradiotherapy alone (standard therapy, n = 238) or gemcitabine and cisplatin induction chemotherapy before concurrent chemoradiotherapy (n = 242). With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9% v 78.8%, hazard ratio, 0.51 [95% CI 0.34 to 0.78]; P =.001) and a comparable risk of late toxicities (≥ grade 3, 11.3% v 11.4%). Notably, the depth of the tumor response to induction chemotherapy correlated significantly and positively with survival (complete response v partial response v stable/progressive disease, 5-year OS, 100% v 88.4% v 61.5%, P =.005). Besides, patients with a low pretreatment cell-free Epstein-Barr virus DNA load (< 4,000 copies/mL) might not benefit from induction chemotherapy (5-year OS, 90.6% v 91.4%, P =.77). In conclusion, induction chemotherapy before concurrent chemoradiotherapy improved OS significantly in patients with locally advanced nasopharyngeal carcinoma, without increasing the risk of late toxicities. Tumor response to induction chemotherapy and pretreatment cell-free Epstein-Barr virus DNA might be useful to guide individualized treatment.

AB - Clinical trials frequently include multiple end points that mature at different times. The initial report, typically on the based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported significantly improved failure-free survival using gemcitabine plus cisplatin induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma. Here, we present the final overall survival (OS) analysis. In this multicenter, randomized trial, patients were assigned to be treated with concurrent chemoradiotherapy alone (standard therapy, n = 238) or gemcitabine and cisplatin induction chemotherapy before concurrent chemoradiotherapy (n = 242). With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9% v 78.8%, hazard ratio, 0.51 [95% CI 0.34 to 0.78]; P =.001) and a comparable risk of late toxicities (≥ grade 3, 11.3% v 11.4%). Notably, the depth of the tumor response to induction chemotherapy correlated significantly and positively with survival (complete response v partial response v stable/progressive disease, 5-year OS, 100% v 88.4% v 61.5%, P =.005). Besides, patients with a low pretreatment cell-free Epstein-Barr virus DNA load (< 4,000 copies/mL) might not benefit from induction chemotherapy (5-year OS, 90.6% v 91.4%, P =.77). In conclusion, induction chemotherapy before concurrent chemoradiotherapy improved OS significantly in patients with locally advanced nasopharyngeal carcinoma, without increasing the risk of late toxicities. Tumor response to induction chemotherapy and pretreatment cell-free Epstein-Barr virus DNA might be useful to guide individualized treatment.

UR - http://www.scopus.com/inward/record.url?scp=85135379945&partnerID=8YFLogxK

U2 - 10.1200/JCO.22.00327

DO - 10.1200/JCO.22.00327

M3 - Article

C2 - 35709465

AN - SCOPUS:85135379945

SN - 0732-183X

VL - 333

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

M1 - JCO.22.00327

ER -

Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial

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